Critical IllnessNCT07613918
Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
An observational study of Critical Illness and Pediatric Critical Illness, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Critical Illness, Pediatric Critical Illness, Respiratory Failure
- What is being tested?
- Transcranial Doppler
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU who meet eligibility criteria
Who may be able to join
- Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English
- Mechanically ventilated (Endotracheal tube)
- Indwelling arterial catheter
- Current patient in the American Family Children's Hospital PICU.
- 1 day to 17.5 years of age
Who cannot join
- Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)
- Patient with known chronic hypertension
- Admission FSS score > 16
- Tracheostomized patient
- The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.
- Not suitable for study participation due to other reasons at the discretion of the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Family Children's Hospital PICU
Madison, Wisconsin, 53792
Talal Al Hendawi, MD
Neil Munjal, MD
About this study
Official title: Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study
This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.
Read the detailed description
Current clinical management of hemodynamics in critically ill children relies primarily on systemic parameters (e.g., blood pressure, heart rate) rather than direct assessment of cerebrovascular regulation. This approach may overlook individual variations in cerebral autoregulation (CA) capacity, potentially leading to suboptimal cerebral perfusion.
By prospectively evaluating TCD-derived CA indices in intubated pediatric patients with arterial blood pressure monitoring, this study aims to:
- Establish normative Cerebral blood flow velocity (CBFV) ranges for critically ill children
- Describe CBFV patterns across critically ill pediatric populations with varying neurologic risk profiles
- Characterize the prevalence of CA dysfunction in a heterogeneous PICU population
- Explore associations between CA/CBFV and functional outcomes
These data could:
- Provide age-stratified CBFV reference values for the PICU setting
- Identify patients at highest risk of neurological morbidity using population-specific thresholds
- Inform future trials of autoregulation-guided hemodynamic management
- Conditions
- Critical Illness, Pediatric Critical Illness, Respiratory Failure, Traumatic Brain Injury, Cardiac Arrest
- Being tested
- Transcranial Doppler
- Keywords
- PICU, infant, Transcranial Doppler Assessment, Cerebral Autoregulation, Blood Flow Velocity, children, mechanical ventilation, neurocritical care, pulsatility index, Mean flow index, neonate, pediatric critical care
- Medical subject headings
- Critical Illness, Respiratory Insufficiency, Brain Injuries, Traumatic, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDevice
Also called TCD
TCD measurements synchronized to arterial blood pressure and ventilatory data, performed once daily for up to 5 days during PICU admission plus one additional pre-extubation scan if applicable, approximately 30 minutes each. Bilateral middle cerebral artery (MCA) insonation performed at each session.
| Study group | Role | What they receive |
|---|---|---|
| PICU Patients | Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU. Receives: Device: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Status Scale (FSS) from baseline to PICU discharge
To assess the relationship between cerebral autoregulation and neurological outcomes in critically ill pediatric patients, FSS will be measured. FSS has 6 domains: mental status, sensory, communication, motor function, feeding, and respiratory. FSS is scored from 6 to 30, higher scores are indicative of more severe dysfunction.
Measured: Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)
Secondary outcomes (6)
Mean Flow Index (Mx)
Mean Flow Index (Mx) will serve as the primary exposure variable in multivariable regression analyses relating cerebral autoregulation status to functional outcome, and will additionally be characterized across PICU subpopulations.
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Percent successful exams (complete bilateral MCA data)
Feasibility metric reflecting the proportion of TCD sessions yielding complete bilateral MCA data, used to assess protocol feasibility and sonographic success rates in the PICU setting.
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Time per exam (min)
Feasibility metric reflecting total time required per TCD session, used to assess protocol efficiency and burden on clinical care.
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Mean CBFV
To describe cerebral blood flow velocity patterns in critically ill pediatric patients, mean CBFV will be measured.
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Age-stratified CBFV values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Age-stratified Mx values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
Measured: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start3 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Munjal, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613918
- Sponsor's protocol ID
- 2026-0238
- Other IDs
- SMPH/Pediatrics/Critical Care, Protocol Version 3/3/26
- Status last verified
- Aug 2026
- First submitted
- 21 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No